Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02490150
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2015-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C437186', 'term': 'follicle stimulating hormone, human, with HCG C-terminal peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total dosis of rFSH (IU)', 'timeFrame': 'donors will be followed until the end of stimulation period, an expected average of 15 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Corifollitropin alfa', 'Stimulation protocol'], 'conditions': ['Oocyte Donation']}, 'referencesModule': {'references': [{'pmid': '24813196', 'type': 'BACKGROUND', 'citation': 'Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length\n* Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations\n* Donors can´t have more than 6 children (neither own or after donations)\n* Not be adopted or being born after a gamete donation pregnancy\n* BMI between 18-28 kg/m2\n* Height \\> 1.55cm\n* Gynecological and general examination with Pap smear, HIV, HCV (hepatitis C virus ), HBV (hepatitis B virus ) and RPR(rapid plasma reagin test ) negative serology, and with normal karyotype\n* No abnormal Psychological profile\n* Discard any disease: blood disorders, neurodegenerative/psychiatric diseases, Fragile X Syndrome, cystic fibrosis carrier, oncology diseases.\n* Without psychological/psychiatric family history\n* Will conform to the protocol for the duration of the study\n* Willingness of adhesion to protocol during the whole study period\n* Signed informed consent\n\nExclusion Criteria:\n\n* Polycystic ovarian syndrome\n* Antral follicle count \\> 20\n* Hypersensitivity to the active substance or any of the excipients\n* Abnormal vaginal bleeding of unknown ethiology\n* Presence of ovarian cysts or increased size ovaries\n* History of ovarian hyperstimulation syndrome\n* Previous controlled ovarian stimulation cycle with more than 30 follicles ≥ 11mm\n* Previous abdominal surgery that contraindicated the practice of follicular puncture\n* HIV, HCV, HBV positive serology in women or partner\n* Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors…)'}, 'identificationModule': {'nctId': 'NCT02490150', 'briefTitle': 'Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Dexeus'}, 'officialTitle': 'Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors', 'orgStudyIdInfo': {'id': 'HDQ-COR-2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Day 5', 'description': 'Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors.', 'interventionNames': ['Drug: Corifollitropin alfa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Day 7', 'description': 'Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors.', 'interventionNames': ['Drug: Corifollitropin alfa']}], 'interventions': [{'name': 'Corifollitropin alfa', 'type': 'DRUG', 'armGroupLabels': ['Day 5', 'Day 7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Quiron Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Dexeus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Francisca Martínez', 'class': 'UNKNOWN'}, {'name': 'Buenaventura Coroleu', 'class': 'UNKNOWN'}, {'name': 'Elisabet Clua', 'class': 'UNKNOWN'}, {'name': 'Ignacio Rodríguez', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Ignacio Rodriguez', 'investigatorAffiliation': 'Fundacion Dexeus'}}}}